Associate Director, PKPD

Overview

About Certara

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees! As one of Certara’s divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables – to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.

Responsibilities

The Associate Director provides leadership for PKPD programming aspects of pharmacokinetics, pharmacodynamics data management by timely completion and high quality of all required deliverables as well as managing a team of PKPD programmers.

• Manage and prepare data for state-of-the-art analysis, such as PPK, PKPD, exposure-response (efficacy or safety) and C-QTc, typically based on CDISC ADaM / SDTM datasets.
• Manage and prepare data for state-of-the-art NCA analysis, such as ADPC, PP and ADPP including the creation of define packages and reviewer guides.
• Write, maintain, and develop high quality Programs (R, SAS) to facilitate the construction of analysis datasets.
• Interact directly with the client on topics around data transfers, dataset specifications and data queries.
• Conduct exploratory analyses of PKPD data in support of modeling analyses.
• Following completion of the project deliverables, you are responsible for creation of an electronic submission package for future submission to regulatory agencies.
• Conduct quality control and quality assurance activities on datasets and reports.
• Initialize or participate in company initiatives to improve quality and efficiency of the PKPD programming process (IT, methodology, automation, quality).
• Ensure that work is delivered on time and within budget to achieve business results.
• Provide training and mentor new hires and junior staff and help to develop data programming skills and efficiencies.
• Coordinate the PKPD programming support for projects and assist Pharmacometricians in finding resources.

Qualifications

• BS, MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
• Minimum 10 years’ experience and expertise in PKPD programming and analysis, report writing, and regulatory drug submissions.
• General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology.
• Expertise in PK/PD programming with strong quantitative skills applied to develop PPK, PKPD, ER-efficacy, ER-safety and C-QTc datasets.
• Expertise in software used for dataset construction (e.g. R, SAS).
• Strong track record of working in various therapeutic areas.
• Familiarity with regulatory requirements and trends with respect to data standards.

Skills & Abilities:

• Advanced user of SAS software (SAS9-Base) with proven experience in life sciences and clinical trials. Familiar in working with CDISC data formats. Experience with the R software platform is a plus.
• Applies innovative approaches to day-to-day work.
• Good project management skills. Accuracy and sense of urgency and quality, timely delivery. Able to take responsibility for executing deliverables according to internal procedures.
• Excellent verbal and written communications skills in English.
• Eager to learn and develop. Informed about current knowledge developments in their area of expertise and actively acquires new skills to keep up to date demonstrating an interest for continuous improvement.
• Ability to work in cross functional project teams.
• Excellent team player and team leader skills.
• Able to work under minimal supervision and make connections across projects.
• Experience in supervising teams with a strong preference for supervision of PKPD programmers and/or statistical programmers.

Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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